Clearance Summary
ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A received FDA 510(k) clearance under submission number K071255, sponsored by Hyphen Biomed. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2007-09-07.
- Submission: K071255
- Applicant / Sponsor: Hyphen Biomed
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7695
- Decision date: 2007-09-07
Classification & Regulation
This clearance is catalogued under FDA product code LCO and 21 CFR 864.7695, within the Hematology review panel as a Class II device.